| CTRI Number |
CTRI/2024/04/065459 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicines in the treatment of Social Anxiety Disorder |
|
Scientific Title of Study
|
Usefulness of Individualized Homoeopathic Medicines on Quality of Life of People Suffering with Social Anxiety Disorder - An Exploratory Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rithi Mutum |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No 1
Fourth Floor
Department of Psychiatry
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park 1
greater noida
NIL
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7005894098 |
| Fax |
|
| Email |
rithimutum143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rithi Mutum |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No 1
Fourth Floor
Department of Psychiatry
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park 1
greater noida
NIL
UTTAR PRADESH
201310
India |
| Phone |
7005894098 |
| Fax |
|
| Email |
rithimutum143@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Chawla |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No 1
Fourth Floor
Department of Psychiatry
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park 1
greater noida
NIL
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9971078406 |
| Fax |
|
| Email |
dr.mansiclinic@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park 1
Greater Noida
Gautam Buddh Nagar 201306
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical Hospital |
| Address |
Room No G 22
Ground Floor
Principal Office
36 B Knowledge Park 1
Greater Noida
Gautam Buddh Nagar 201306
Uttar Pradesh
Principal Office
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park 1
greater noida |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rithi Mutum |
Bakson homoeopathic Medical College and Hospital |
Outpatient Department (OPD)
Room No 1
Ground Floor
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park 1
greater noida 201310
Gautam Buddha Nagar
UTTAR PRADESH |
7005894098
rithimutum143@gmail.com |
| Dr Rithi Mutum |
Dr D P Rastogi Central Research Institute of Homoeopathy |
Out Patient Department (OPD)
Room No 110
Ground Floor
A 1/1 Sector 24
Noida 201301
Gautam Buddha Nagar
UTTAR PRADESH |
7005894098
rithimutum143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bakson Homoeopathic Medical College & Hospital |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
15 months study
6 months enrollment
6 months follow ups
3 months analysis
Oral Route of Administration
pill form
30 pill size
Centesimal Scale
first dose after taking the case
subsequent doses after each follow up
potency according to the case |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Age Group 10 to 18 years
Both gender
patient who fulfill criteria according to DSM V
Marked Fear about social situations
social situations are avoided
anxiety more than actual threat
symptoms for atleast 6 months
symptoms cause distress |
|
| ExclusionCriteria |
| Details |
Patients with other psychiatric illness PTSD GAD OCD Panic Disorder Substance abuse
patient with ongoing medication for other diseases
cases with life threatening illnesses requiring emergency or surgery
patients with SAD with physical deformity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| it is expected to have positive changes on LSAC Scale |
15 Months study
6 Months enrollment
6 months Follow Up
3 months data analysis
LSAC Scale to be used at Baseline, 4 weeks, 8 weeks, 12 weeks till 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it is expected to have positive changes on WHO-QOL BREF Scale |
15 Months study
6 Months enrollment
6 months Follow Up
3 months data analysis
WHO-QOL BREF Scale to be used at Baseline, 4 weeks, 8 weeks, 12 weeks till 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to assess the role of Homoeopthic medicines in the treatment of Social Anxiety Disorder. Sample size is 47. Single arm Study. 15 months study Scale used for screening the sample- SPIN Scales used for assessment - LSAC and WHOQOL BREF. it is expected to see positive changes in the LSAC and WHOQOL BREF Scale. |